During the past year, we published three papers in this project. All were normative analyses papers, focusing on the risk-benefit analysis of pragmatic comparative effectiveness RCTs and on the continuing discussions of ethically acceptable modifications of informed consent for such trials. Chen S, Kim SYH. A Framework for Analysis of Research Risks and Benefits to Participants in Standard of Care Pragmatic Clinical Trials. Clinical Trials. 2016 doi: 10.1177/1740774516656945. Kim SYH. Clinical Trials Without Consent? Perspectives in Biology and Medicine. 2016; 59 (1), 132-146. DOI: 10.1353/pbm.2016.0023 Kim SYH, Miller FG. Ethical Complexities in Standard of Care Randomized Trials: A Case Study of Morning Versus Nighttime Dosing of Blood Pressure Drugs. Clinical Trials. 12(6), 557-563. doi: 10.1177/1740774515607213.